(87 days)
Oncentra Prostate is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources The software should only be used by a person trained in brachytherapy techniques (such a person will be referred to as the user).
Oncentra Prostate is a "real time" treatment planning system for brachytherapy, specially designed for the treatment of prostate cancer. Direct 3D ultrasound imaging of the implant gives the possibility to update the treatment plan during insertion of the catheters in the prostate. Before treatment, the software provides the physician with anatomical and dosimetric information, which is used to determine the positioning and loading of radioactive sources. The software also provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution (e.g. dose verification at a point and dose volume histograms).
Here's a breakdown of the acceptance criteria and study information for the Oncentra Prostate 4.0 device, based on the provided text:
Key Takeaways Before Diving In:
- No Clinical Study: The most crucial point is that "Clinical testing was not required to demonstrate substantial equivalence." This means there was no clinical study conducted to establish acceptance criteria or prove device performance in a real-world clinical setting.
- Focus on Non-Clinical Verification: The submission relies entirely on non-clinical testing and comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) from a clinical study are provided, this table will reflect the general statements made in the document regarding non-clinical performance.
| Acceptance Criteria Category (Implied) | Stated Device Performance |
|---|---|
| Safety and Effectiveness | "Oncentra Prostate 4.0 functions conform its specifications, is safe and effective for its intended use..." |
| Performance vs. Predicate Device | "...and performs as well as or better than its predicate devices." |
| Hazard Analysis | "All relevant hazards were analyzed and appropriate measures were verified." |
| Dose Calculation Accuracy | "Dose calculation was validated against reference standards in the same way as dose calculations of the predicate devices were validated." |
| Functionality | "Oncentra Prostate 4.0 functions conform its specifications..." |
| Substantial Equivalence | Demonstrated through comparison to predicate devices (Swift 2.0 and Spot Pro). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. No clinical test set was used for performance evaluation.
- Data Provenance: Not applicable. No clinical data was used for performance evaluation. The "non-clinical testing" likely involved internal engineering tests, software validation, and comparison to theoretical models or existing data sets from predicate devices, but details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. No clinical test set with expert-established ground truth was used.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
- MRMC Study: No. The document explicitly states, "Clinical testing was not required to demonstrate substantial equivalence." The device is a treatment planning system, not an AI diagnostic tool designed to assist human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of typical AI performance studies. While the software has standalone functions (e.g., dose calculation, auto-contouring), the document doesn't provide specific standalone performance metrics (e.g., accuracy of auto-contouring compared to ground truth) or a study design for evaluating this. It states that "non-clinical testing" and "verification and validation was performed according Nucletron’s procedures" and that "Dose calculation was validated against reference standards." These are internal quality and verification checks, not formal standalone performance studies in a regulatory sense that would typically involve a human-generated ground truth and associated metrics.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical testing mentioned:
- Reference Standards: For dose calculation validation. The exact nature of these standards (e.g., phantom measurements, theoretical models, established physics data) is not detailed.
- Specifications: The device's functions were tested against its own design specifications.
- Predicate Device Performance: The device's overall performance was benchmarked against existing legally marketed devices (Swift 2.0 and Spot Pro), implying that their established performance serves as an indirect "ground truth" for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The document does not describe the device as a machine learning or AI model that requires a "training set" in the conventional sense. It's a software application for brachytherapy treatment planning. If it uses any internal algorithms that were "trained," this information is not disclosed.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set was Established: Not applicable, as there's no mention of a traditional training set for a machine learning model.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.